ObesityNCT01686399
A Sustainable Diet for Hadassah Employees Workers
A study testing Nutritional and Activity Promotion in people with Obesity and Physical Activity, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused… Read more about this study
- Who is it for?
- Ages 21 to 67 years
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Nutritional and Activity Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hadassah medical center employees Age 21-67
- -
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Dorit Adler, MPH contact
About this study
Official title: A Sustainable Diet for Hadassah Employees
The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen.
The outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. Outcomes will be recorded at baseline and by the end of the intervention ( one year).
Read the detailed description
The participants will be selected randomly from the campus employees. They will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. Analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. A second group from the employees will be selected for assessment of the same outcomes at the end of the year.
- Conditions
- Obesity, Physical Activity
- Being tested
- Nutritional and Activity Promotion
- Keywords
- Sustainable diet, Health promotion, Obesity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and Activity PromotionBehavioural
Multi disciplinary nutritional and behavioral messages to improve diet and activity levels
| Study group | Role | What they receive |
|---|---|---|
| The study has a single arm | Experimental | The study has one arm The whole population of the campus will be exposed to the intervention. the effectiveness will be assessed using a random selection twice - before and after the intervention Receives: Behavioral: Nutritional and Activity Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amount of fruit/vegetable consumption per day
Amount of fruit/vegetable consumption will be evaluated via questionnaires
Measured: one year
Secondary outcomes (1)
Amount of physical activity per week
Amount of physical activity will be assessed via questionnaires
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ram Weiss, Hadassah Medical Organization
- Investigators
- Ram Weiss, MD PhD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686399
- Sponsor's protocol ID
- HMO 0645-11
- Status last verified
- Mar 2015
- First submitted
- 9 Sep 2012
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sustainable Diet for Hadassah Employees
- ClinicalTrials.gov ID
- NCT01686399
- Acronym / sponsor ID
- HMO 0645-11
- Conditions
- Obesity, Physical Activity
- Keywords
- Sustainable diet, Health promotion, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen.
The outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. Outcomes will be recorded at baseline and by the end of the intervention ( one year).
Detailed description
The participants will be selected randomly from the campus employees. They will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. Analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. A second group from the employees will be selected for assessment of the same outcomes at the end of the year.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study has a single arm | Experimental | Behavioral: Nutritional and Activity PromotionThe study has one arm The whole population of the campus will be exposed to the intervention. the effectiveness will be assessed using a random selection twice - before and after the intervention |
Who may qualify
- Ages
- 21 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hadassah medical center employees Age 21-67
- -
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional and Activity PromotionMulti disciplinary nutritional and behavioral messages to improve diet and activity levels | Behavioural | The study has a single arm |
Primary outcome
Change in amount of fruit/vegetable consumption per day
Time frame: one year
Amount of fruit/vegetable consumption will be evaluated via questionnaires
1 secondary outcome
Amount of physical activity per week
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorit Adler, MPH contact
Ram Weiss, MD PhD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and Activity Promotion in people with Obesity and Physical Activity, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorit Adler, MPH (02677551), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amount of fruit/vegetable consumption per day (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.